[Asia Economy Reporter Cho Hyun-ui] The Ministry of Food and Drug Safety (MFDS) is under suspicion of granting conditional approval for the COVID-19 treatment drug Remdesivir despite being aware of side effects that occurred during the domestic Phase 3 clinical trial.
According to data received by Kang Ki-yoon, a member of the National Assembly's Health and Welfare Committee from the People Power Party, from the MFDS on the 28th, the MFDS was informed in April of one case of the side effect "decreased heart rate" that occurred during the Phase 3 clinical trial of Remdesivir conducted at Seoul Medical Center from March 27 to June 25, but approved the use of the drug on July 24.
Conditional approval is granted on the condition that the final results of internationally conducted clinical trials, some manufacturing and quality control standard data, and additional risk mitigation measures are submitted post-marketing.
Before conditional approval, the MFDS supplied Remdesivir domestically through a special import system. At the time of conditional approval, the MFDS stated, "Although supply was made through special import approval from June, we decided to grant product approval to secure a stable supply due to the prolonged COVID-19 situation."
Health authorities confirmed adverse reactions in COVID-19 patients who received Remdesivir in August. These included elevated liver enzyme levels, hives and rash, and premature ventricular contractions of the heart.
As of the 7th of this month, a total of 274 COVID-19 patients in Korea have been administered Remdesivir. Among them, 16 deaths have been reported.
Assemblyman Kang Ki-yoon pointed out, "Regardless of the severity of the side effects, if side effects occurred in domestic clinical trials, that fact should be transparently disclosed," and added, "Since adverse reactions may occur in elderly COVID-19 patients with underlying cardiovascular diseases, additional research and verification are necessary."
© The Asia Business Daily(www.asiae.co.kr). All rights reserved.
